1. amal therpeutics
  2. transgene s.a
  3. intrexon t1d partners, llc
  4. vion pharmaceuticals, inc
  5. bejing institute of biotechnology, cansino biologics inc,
  6. theravectys
  7. sangamo therapeutics
  8. schering plough nv/sa
  9. f. hoffmann-la roche
  10. transgene s.a.
  11. Search the database for deliberate release of GM medicinal products

Search the database for deliberate release of GM medicinal products

Displaying 1 - 14 of 14
EU record number Title Company / Sponsor Treated organism Genetic modification
B/BE/22/BVW5 A two-part, open-label systemic gene delivery study to evaluate the safety and expression of RO7494222 (SRP-9001) in subjects under the age of four with Duchennne Muscular Dystrophy (ENVOL) F. Hoffmann-La Roche Humans Non-replicating recombinant vector derived from adeno-associated virus AAV, serotype rh74, lacking all AAV viral genes and carrying the human micro-dystrophin (hMicro-Dys) gene
​B/BE/21/BVW4 An Open-Label, Multicenter, Non-Randomized, Dose-Confirmation and Cohort-Expansion Phase 1b Study to Evaluate the Safety, Tolerability, and Anti-Tumor Activity of ATP128, VSV-GP128 and BI 754091, in Patients with Stage IV Colorectal Cancer AMAL Therpeutics Humans VSV-GP128 is a recombinant live-attenuated Vesicular Stomatitis Virus (VSV), modified to minimize the potential of neurotoxicity for humans and skin disease in animals, and engineered to contain cancer antigens, which help it induce an immune response against colorectal tumour cells.
Only notified under the "contained use" procedure. Dossier submitted on 03/05/2021. Administration of genetically engineered T cells (KTE-X19) in Pediatric and Adolescent Subjects with Relapsed/Refractory B-precursor Acute Lymphoblastic Leukemia or Relapsed/Refractory B-cell Non-Hodgkin Lymphoma Kite Pharma Humans CD19-CAR
Only notified under the "contained use" procedure. Dossier submitted on 02/12/2019. A multicentre, open-label, single ascending dose, dose-ranging, phase I/Iia study to evaluate the safety and tolerability of an autologous antigen-specific chimeric antigen receptor T regulatory cell therapy (TX200-TR101) in living donor renal transplant Sangamo therapeutics Humans chimeric antigen receptor specific to the donor HLA A*2
EBOVEU001 A phase IIa partial blind, placebo-controlled clinical trial to evaluate the safety and immunogenicity of the Ad5-EBOV in healthy adults aged between 18 and 60 years in Belgium. Bejing Institute of Biotechnology, CanSino Biologics Inc, Humans Recombinant Adenoviral vector serotype 5 expressing the envelop glycoprotein from Ebola virus (Zaïre-Makona)
B/BE/18/BVW5 A Phase 1b/2a study to assess the safety and tolerability of GM Lactococcus lactis in subjects with Type 1 Diabetes Mellitus Intrexon T1D Partners, LLC Humans Biologically contained strain of Lactococcus lactis, genetically modified to secrete human interleukin-10 and proinsulin
Only notified under the "contained use" procedure. Dossier submitted on 25/04/2018. A Phase 3, Randomized, Open-Label Study Evaluating the Efficacy of Axicabtagene Ciloleucel versus Standard of Care Therapy in Subjects with Relapsed/Refractory Diffuse Large B Cell Lymphoma (ZUMA-7) Kite Pharma Humans Chimeric antigen receptor against CD19
B/BE/12/BVW1 A multi-center, randomized, double-blind, placebo-controlled Phase I/II trial to compare the safety, tolerability and immunogenicity of the therapeutic THV01 vaccination of HIV-1 clade B infected patients under highly antiretroviral therapy TheraVectys Humans genes encoding the epitopes of the HIV-1 Gag, Pol and Nef proteins
B/BE/03/B3 Phase I multicentre study of TG1024 (Adenovirus interleukin 2) in patients with metastatic melanoma or other advanced solid tumor cancers Transgene S.A. Humans gene coding for human interleukin 2
B/BE/02/B7 Phase II study evaluating the clinical efficacy of TG4010 (MVA-MUC1-IL2) in patients with metastatic Renal Cell Carcinoma (RCC) Transgene S.A. Humans sequences coding for the human MUC-1 antigen and IL-2
B/BE/01/B7 Specific immunotherapy against MUC-1 antigen - Study TG4010.04 : "Phase II study with TG4010(MVA-MUC-1-IL-2) in patients with metastatic breast cancer", Study TG4010.05 : "Phase II study with TG 4010 in patients with non small cell lung cancer" Transgene S.A. Humans sequences coding for the human MUC-1 antigen and IL-2
B/BE/98/B6 Clinical research program : Gene-therapy by the Use of a Recombinant Adenovirus in the Treatment of p53 Deficient Cancers Schering Plough NV/SA Humans wild-type p53 tumor suppressor gene
Only notified under the "contained use" procedure. Dossier submitted on 18/08/1997. A phase II gene therapy study in patients with non-small cell lung cancer using SCH58500 (rAd/p53) in combination with chemotherapy for multiple cycles Schering Plough NV/SA Humans Wild-type p53
Only notified under the "contained use" procedure. Dossier submitted on 21/10/1996. A phase I study in patients with recurrent or metastatic squamous cell carcinoma of the head and neck using SCH 58500 (rAd/p53) administered by single intratumoral injection Schering Plough NV/SA Humans Wild-type p53